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Home » India Launches Consultation on Fixed-Dose Combinations Including Investigational Drugs
India Launches Consultation on Fixed-Dose Combinations Including Investigational Drugs
September 16, 2010
Sponsors of fixed-drug combinations (FDC) where one of the ingredients is an investigational drug must submit Phase I through III clinical trial data in order to obtain marketing authorization, India’s Central Drugs Standard Control Organization (CDSCO) says in new draft guidance.
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